Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
tada: Another issue with FDA's RSABE (please confirm?) Phoenix/WinNonlin: not confirmed Phoenix/WinNonlin: not confirmed TRT\|RTR or FA0(1) TRT\|RTR or FA0(1) Partial replicate crap? Really? Partial replicate crap? Really? Tweak & Fiddle Tweak & Fiddle Not confirmed - SAS	jag009	2013-12-19 17:41	9	2013-12-23 13:06	11,598
Three Formulation - Partial Replicate Three Formulation - Partial Replicate Randomization? Randomization? Randomization? Randomization? not randomized! not randomized! CVwr	K2K	2013-10-18 10:05	8	2013-10-31 15:25	10,374
Widening Cmax in EU Widening Cmax in EU EMA: ABEL EMA: ABEL	Clarc	2013-10-24 14:55	3	2013-10-28 09:04	7,153
Fully Replicated design Fully Replicated design Fully Replicated design RR values only RR values only RR values only RR values only RR values only RR values only	sirajudeen	2013-09-24 07:00	8	2013-10-24 07:01	10,582
Clarification on model statement in EMEA submission EMA: all effects fixed EMA: all effects fixed EMA: all effects fixed - Method A! EMA: Method C “incompatible with CHMP GL” EMA: Method C “incompatible with CHMP GL”	RK	2013-10-08 13:39	5	2013-10-10 04:01	7,970
Partial replicate designs Partial replicate designs Partial replicate designs Partial replicate designs Partial replicate designs OT	The Outlaw Torn	2013-09-25 08:21	5	2013-09-26 06:56	7,768
fully replicate design with six sequences Objective? Objective? Objective? Objective? (again) Question: Imbalanced/incomplete sequences fully replicate design with four sequence Period effects and sequences unrelated Period effects and sequences unrelated	RK	2013-09-14 12:17	9	2013-09-24 11:16	11,427
Intersubject CV from Proc mixed (partial replicate study) Intersubject CV from Proc mixed Intersubject CV from Proc mixed G matrix and OT G matrix and OT	jag009	2013-08-28 20:13	4	2013-09-04 15:29	7,894
3-per, 2-trt designs and estimation of intra-subj. variance 3-per, 2-trt designs and estimation of intra-subj. variance 3-per, 2-trt designs and estimation of intra-subj. variance TRT\|RTR rulez! TRT\|RTR rulez? Really? TRT\|RTR rulez? Really? Yes. TRT\|RTR rulez? Really? No. TRT\|RTR rulez? Really? No. TRT\|RTR Lost in formulas. TRT\|RTR rulez? References References László & László Heteroscedasticity Heteroscedasticity: TRT\|RTR rulez! Heteroscedasticity: TRT\|RTR rulez! Sims & evaluation Sims & evaluation Evaluation subtleties	ElMaestro	2013-08-12 19:54	16	2013-08-31 15:20	14,384
RSAB model overspecified RSAB model overspecified Proc Mixed FA0(1) for partial replicate Proc Mixed FA0(1) for partial replicate Proc Mixed FA0(1) for partial replicate Proc Mixed FA0(1) for partial replicate Proc Mixed FA0(1) for partial replicate Proc Mixed FA0(1) for partial replicate FA0(1) for partial replicate in Phoenix FA0(1) for partial replicate in SAS FA0(1) for partial replicate in Phoenix FA0(1) in PHX: works (& more questions)	Wolfgang	2013-08-05 14:37	11	2013-08-30 15:07	14,047
Partial Replicate vs Full Replicate study design Partial Replicate vs Full Replicate study design Partial Replicate vs Full Replicate study design Partial Replicate vs Full Replicate study design	jag009	2013-08-23 16:46	3	2013-08-26 13:42	11,940
RASBE - 95% upper confidence bound RASBE - 95% upper confidence bound	jag009	2013-06-05 22:48	1	2013-06-06 07:13	4,896
CI calculation in full replicate design CI calculation in full replicate design CI calculation in full replicate design CI not needed in RSABE CI not needed in RSABE CI calculation in full replicate design	Ken Peh	2013-06-03 19:11	5	2013-06-05 17:56	7,234
Clarification on HVD paper	jag009	2013-05-13 16:56	0		3,084
Reporting RSABE to the FDA Reporting RSABE to the FDA	Helmut	2013-05-03 01:03	1	2013-05-03 14:37	6,348